Abstract
Rheumatoid arthritis (RA) is a chronic autoimmune disorder, often treated with adalimumab. This study was designed to validate usability of the adalimumab biosimilar FKB327 auto-injector (AI) and document risk associated with the device. A total of 136 participants were enrolled, including patients with RA, caregivers of patients with RA, and healthcare providers of patients with RA. Use errors and close calls were evaluated during 2 simulated injections. A full dose was administered by 90.4% and 97.8% of users for the first and second injections, respectively. The most common use errors were failure to squeeze injection site, check expiration date, check medication in viewing window, and rotate injection site during the second injection. The device, packaging, and instructions received favourable user ratings. FKB327-AI is an easy-to-use device for patients with RA, their caregivers, and healthcare providers. Errors that could lead to incorrect dose were infrequent and not associated with serious harm.
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